A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma
NCT ID: NCT01984242
Last Updated: 2019-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
305 participants
INTERVENTIONAL
2014-01-08
2019-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab and Bevacizumab
Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) will be administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Atezolizumab will be administered according to the dosage schedule mentioned in the arm description.
Bevacizumab
Bevacizumab will be administered according to the dosage schedule mentioned in the arm description.
Atezolizumab
Atezolizumab 1200 mg will be administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except European Union \[EU\] participants) can crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Atezolizumab will be administered according to the dosage schedule mentioned in the arm description.
Bevacizumab
Bevacizumab will be administered according to the dosage schedule mentioned in the arm description.
Sunitinib
Sunitinib 50 mg will be administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants can crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Atezolizumab will be administered according to the dosage schedule mentioned in the arm description.
Bevacizumab
Bevacizumab will be administered according to the dosage schedule mentioned in the arm description.
Sunitinib
Sunitinib will be administered according to the dosage schedule mentioned in the arm description.
Interventions
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Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Atezolizumab will be administered according to the dosage schedule mentioned in the arm description.
Bevacizumab
Bevacizumab will be administered according to the dosage schedule mentioned in the arm description.
Sunitinib
Sunitinib will be administered according to the dosage schedule mentioned in the arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease, as defined by RECIST v1.1
* Karnofsky performance score greater than or equal to (\>/=) 70
* Adequate hematologic and end-organ function as defined by protocol
* Women of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective methods of contraception as defined by protocol
Exclusion Criteria
* Radiotherapy for renal cell carcinoma within 14 days prior to Cycle 1, Day 1 with the exception of single-fraction radiotherapy given for the indication of pain control
* Known active malignancies or metastasis of the brain or spinal cord or leptomeningeal disease, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* Uncontrolled hypercalcemia or symptomatic hypercalcemia
* Malignancies other than renal cell carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome
General Medical Exclusions:
* Life expectancy of less than (\<) 12 weeks
* Pregnant and lactating women
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
* Participants with active or chronic hepatitis B, active hepatitis C, Human Immunodeficiency Virus (HIV) positive test, significant cardiovascular disease
* Prior allogeneic stem cell or solid organ transplant
* Prior treatment with Cluster of Differentiation 137 (CD137) agonists, anti-Cytotoxic T-Lymphocyte Antigen-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
* Treatment with systemic immunostimulatory agents for any reason within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
* Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1
Bevacizumab- and Sunitinib-Specific Exclusions:
* Inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association Class II or greater congestive heart failure
* History of myocardial infarction or unstable angina, stroke or transient ischemic attack within 3 months prior to Cycle 1, Day 1
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCLA
Los Angeles, California, United States
University of California
San Francisco, California, United States
Univ Colorado Health Sci Ctr
Aurora, Colorado, United States
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver, Colorado, United States
Yale Uni School of Medicine; Section of Medical Oncology
New Haven, Connecticut, United States
Georgetown U; Lombardi Comp Can
Washington D.C., District of Columbia, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute.
Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Memorial Sloan-Kettering
New York, New York, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Cleveland Clinic Foundation; Taussig Cancer Center
Cleveland, Ohio, United States
Oncology Associates of Oregon, P.C
Eugene, Oregon, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris, , France
CHU Bordeaux
Pessac, , France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, , France
Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
Hanover, , Germany
Klinikum d.Universität München Campus Großhadern
München, , Germany
Klinikum rechts der Isar der TU München; Klinikapotheke
München, , Germany
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, Italy
Medical Oncology, Arezzo
Arezzo, Tuscany, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, Italy
Centrum Med. Ostrobramska NZOZ Magodent
Warsaw, , Poland
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, , Romania
Medisprof SRL
Cluj-Napoca, , Romania
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
Barcelona, , Spain
Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal
Madrid, , Spain
Barts and the London NHS Trust.
London, , United Kingdom
Royal Marsden Hospital - London
London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
Countries
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References
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Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
Pal SK, McDermott DF, Atkins MB, Escudier B, Rini BI, Motzer RJ, Fong L, Joseph RW, Oudard S, Ravaud A, Bracarda S, Suarez C, Lam ET, Choueiri TK, Ding B, Quach C, Hashimoto K, Schiff C, Piault-Louis E, Powles T. Patient-reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma. BJU Int. 2020 Jul;126(1):73-82. doi: 10.1111/bju.15058. Epub 2020 Apr 24.
Other Identifiers
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2013-003167-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO29074
Identifier Type: -
Identifier Source: org_study_id